Soft Tissue Biopsy Device

ABSTRACT

A soft tissue biopsy aspirating device for gathering soft tissue samples comprising a syringe having a barrel, with a reciprocably movable plunger sealingly received within the barrel to form a chamber with a controllably variable volume, and with a hollow sample-receiving needle mounted on a needle mounting boss attached to the barrel. The needle mounting boss has a rigid needle mounting shaft coupled on the end thereof, the shaft having a bore formed therein with a longitudinal segment and a radial segment to provide communication between the hollow core of the needle and the barrel with sample blocking means having an angularly disposed abutment surface thereon being provided to arrest inward motion of the sample and retain the sample so obtained in a stable position to prevent direct contact between the sample and the bore formed in the shaft. The plunger is secured to the conventional gripping shaft, and the gripping shaft has means for releasably engaging the proximate end of the barrel at controllable axial dispositions therealong. In use, the needle is used to puncture the body, and the tip of the needle is advanced until it reaches a point adjacent the organ from which the soft tissue is to be collected. At this point, the plunger is withdrawn and locked into engagement with the barrel, so as to form a partial vacuum within the barrel. The advancement of the needle is continued, thereby gathering a sample of tissue from the desired organ, with the tissue sample moving into the needle shank until contact is made with the abutment surface. The rigid needle mounting shaft supports and stabilizes the needle.

United States Patent [1 1 J amshidi [4 1 May 13,1975

[ SOFT TISSUE BIOPSY DEVICE Khosrow Jamshidi, 610 Winston Ct., St. Paul,Minn. 55118 [76] Inventor:

[52] US. Cl 128/2 B; 128/218 C; 128/347; 128/329 [51] Int. Cl A61b 10/00[58] Field of Search 128/2 8,2 R, 310, 329, 128/347, 278, 218 C [56]References Cited UNITED STATES PATENTS 2,844,148 7/1958 Raife 128/218 C2,869,541 l/l959 Helmer et al. 128/218 C 3,330,268 7/1967 Goldsmith128/2 B 3,470,867 10/1969 Goldsmith 128/2 B 3,540,447 11/1970 Howe etal... 3,628,524 12/1971 Jamshidi 3,727,602 4/1973 I-Iyden et al. 128/2 BFOREIGN PATENTS OR APPLICATIONS 587,586 l/l959 Italy 128/2 B PrimaryExaminer-Kyle L. Howell [5 7] ABSTRACT A soft tissue biopsy aspiratingdevice for gathering soft tissue samples comprising a syringe having abarrel,

with a reciprocably movable plunger sealingly received within the barrelto form a chamber with a controllably variable volume, and with a hollowsamplereceiving needle mounted on a needle mounting boss attached to thebarrel. The needle mounting boss has a rigid needle mounting shaftcoupled on the end thereof, the shaft having a bore formed therein witha longitudinal segment and a radial segment to provide communicationbetween the hollow core of the needle and the barrel with sampleblocking means having an angularly disposed abutment surface thereonbeing provided to arrest inward motion of the sample and retain thesample so obtained in a stable position to prevent direct contactbetween the sample and the bore formed in the shaft. The plunger issecured to the conventional gripping shaft, and the gripping shaft hasmeans for releasably engaging the proximate end of the barrel atcontrollable axial dispositions therealong. In use, the needle is usedto puncture the body, and the tip of the needle is advanced until itreaches a point adjacent the organ from which the soft tissue is to becollected. At this point, the plunger is withdrawn and locked intoengagement with the barrel, so as to form a partial vacuum within thebarrel. The advancement of the needle is continued, thereby gathering asample of tissue from the desired organ, with the tissue sample movinginto the needle shank until contact is made with the abutment surface.The rigid needle mounting shaft supports and stabilizes the needle.

9 Claims, 6 Drawing Figures PATENTED HAY l 3|975 SOFT TISSUE BIOPSYDEVICE CROSS-REFERENCE TO RELATED APPLICATION The present applicationrelates to a device which is an improvement over that disclosed andclaimed in copending application Ser. No. 330,320, filed Feb. 7, 1973,entitled SOFT TISSUE BIOPSY ASPIRATING DEVICE AND METHOD OF USING SAME,which application formed a continuation-in-part of then copendingapplication Ser. No. 261,8l8, filed June 12, 1972 and entitled SOFTTISSUE BIOPSY ASPIRAT- ING DEVICE AND METHOD OF USING SAME, nowabandoned. 4

BACKGROUND OF THE INVENTION The present invention relates generally toan improved biopsy aspirating device for obtaining tissue samples, andmore particularly, to an improved biopsy aspirating device particularlydesigned to gather tissue samples of soft tissue organs, such as liver,kidney, spleen, thyroid or the like. The apparatus of the presentinvention is particularly adapted to obtain tissue samples withoutrequiring unusual surgical procedures, and without requiring that largeopenings be formed within the body; and is further adapted to retainsuch samples without exposing the sample structure to risk of damage dueto the exertion of unusual forces upon the substance of the tissuesample. The apparatus of the present invention is also designed so as toprovide means for supporting, stabilizing, and mechanically reinforcingthe hollow needle, the hollow needle devices nor mally being fabricatedfrom thin-walled stainless steel tubing, and frequently being brittleand subject to breakage during use.

At the present time, a variety of specific biopsy instruments are beingutilized for obtaining biopsy test specimens from various organs,however, such instruments are normally cumbersome when being utilizedfor obtaining biopsy specimens from internally disposed organs whichtend to bleed profusely when specimens are removed therefrom. It isdeemed desirable, therefore, to utilize a device which reduces thecomplexity of the procedure for the operator, thereby reducing the riskof complications resulting therefrom; and also to utilize apparatuswhich neither damages nor destroys the specimen when obtained.

SUMMARY OF THE INVENTION Briefly, in accordance with the presentinvention, a biopsy aspirating device is provided which is specificallyadapted for gathering soft tissue samples, and comprises a syringehaving a barrel, a plunger which is sealingly received for reciprocatorymotion within the barrel to form a chamber with a controllably variablevolume, and with a sample receiving hollow needle having a sharpened tipbeing disposed on the end of the barrel. The syringe is provided withneedle mounting boss means for being received within the hub of theneedle, with a bore being formed in the boss to provide communicationbetween the needle bore and the barrel chamber. An inner reinforcingshaft is provided, with this shaft being mounted within the boss, andhaving a bore formed therein which provides direct communication betweenthe barrel chamber and the needle bore. The bore formed in the shaft isprovided with an off-set segment which extends radially outwardly to theperipheral surface of the shaft, thereby minimizing the risk of anyportion of the sample coming into contact with the communication linkbetween the barrel chamber and the needle bore. Furthermore, the shafthas an abutment surface at the forward end thereof, with this abutmentsurface being provided to engage the sample and retain the sample in aposition to prevent direct contact between the sample and the boreformed in the boss. The shaft is closely spaced from the interior wallsof the hollow needle, thus providing a reinforcing or supporting corefor the hollow needle. The needle plunger is provided with a grippingshaft having locking means for retaining the plunger at a point removedfrom the base of the barrel, so as to maintain a controlled partialvacuum within the chamber. In use, the needle is inserted into thepatient until the distal tip is disposed immediately adjacent the organfrom which the sample is to be obtained. The plunger is then withdrawnor retracted within the barrel and locked in place so as to create andmaintain a partial vacuum within the chamber. With the plunger retainedin locked disposition, the needle is immediately advanced until the tippenetrates the organ, and when advancement ceases, the partial vacuumpresent in the chamber will extract the sample from the organ and drawit further into the needle bore until contact is made with the abutmentsurface. The abutment surface formed at the tip of the shaft preventsthe sample from passing along the length of the needle and into contactwith the opening of the bore formed in the boss, thereby preserving theintegrity of the sample at a point within the needle bore and inwardlyfrom the needle tip. If desired, after removal of the biopsy needle, acauterizing device or cryoprobe may be inserted into the opening formedby the needle for the purpose of cauterizing the wound formed along thebiopsy track.

Therefore, it is a primary object of the present invention to provideapparatus and technique for obtaining biopsy samples or specimens fromsoft tissue organs such as liver, kidney, spleen or they like, withmeans being provided for controllably positioning the sample against anabutment surface, thereby maintaining the integrity of the sample whilecontinuously subjecting the sample to an aspirating force.

It is a further object of the present invention to provide apparatus andtechnique for obtaining biopsy samples or specimens from soft tissueorgans pursuant to a simplified technique and without requiring thosemoderately extensive surgical procedures which may at times be required.

It isyet a further object of the present invention to provide improvedapparatus and technique for obtaining biopsy samples or specimens fromsoft tissue organs wherein the sample is maintained in a condition freefrom exposure to unusual forces.

Other and further objects of the present invention will become apparentto those skilled in the art upon a study of the following specification,appended claims, and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a side elevational view ofthe biopsy aspirating device fabricated in accordance with the presentinvention, and showing the disposition of the plunger and its grippinghandle partially removed from the base of the barrel;

FIG. 2 is a view similar to FIG. 1 and showing the disposition of theplunger when removed a substantial distance from the base of the barreland with a segment of the hollow needle being cut away so as to exposethe needle mounting shaft therewithin;

FIG. 3 is a perspective view of the proximate end only of the apparatusshown in FIGS. 1 and 2, with the remainder being broken away;

FIG. 4 is an end view, on a slightly enlarged scale illustrating theproximate end of the structure, and with a portion of the plunger memberbeing shown in section and in unlocked disposition with the barrelstructure;

FIG. 5 is a view similar to FIG. 4 and illustrating the plunger inlocked disposition with the barrel; and

FIG. 6 is a vertical sectional view, on a significantly enlarged scale,illustrating the details of the needle and needle supporting shaft.

DESCRIPTION OF THE PREFERRED EMBODIMENT In accordance with the preferredembodiment of the present invention, particular attention is initiallydirected to FIGS. 1, 2 and 6 of the drawings wherein the preferredmodification of the structure is illustrated in detail. Essentially, thebiopsy aspirating device generally designated 11) includes a barrelmember 11 having a plunger 12 sealingly received within the barrel andforming a chamber zone as at 13. A sample-receiving hollow needle 15 isprovided having a sharpened tip 16 and a hub 17 for locking onto the tipend of the barrel 11 with the sample receiving hollow needle 15 having ashank portion interposed between the sharpened tip 16 and the hub 17.

A needle mounting boss means 20 is arranged at the distal or tip end ofbarrel 11, with the boss means 20 extending from the barrel with needlehub-receiving surface 21 being disposed therealong. Needle mountingshaft 22 having an inner end portion 23 disposed within the confines ofboss 20, and with the free end of the needle mounting shaft beingdisposed coaxially within the bore of the hollow needle 15. Alongitudinal bore segment is provided as at 23A, with a radial segmentbeing provided at 238 in order to achieve continuous communicationbetween the chamber Zone 13 of barrel 11 and the hollow core portion ofneedle 15. As illustrated in FIG. 6, the forward end portion 24 ofneedle mounting shaft 22 is an angularly disposed abutment surface formaking contact with soft tissue samples entering the core of needle 15.In other words, the abutment surface provides a blocking surface whichavoids exposing the tissue sample to an unusual concentration of forcesor pressures. This feature will be discussed in detail hereinafter.

It will be further observed that the boss means 20 is arranged to bereceived within the hub 17. The bore segments 23A and 2313 in needlemounting shaft 22 may be small in diameter, and in particular, smallrelative to the inner diameter of the hollow needle 15. This permitsgaseous fluids to freely pass through the needle, as well as blood andother body fluids, while preventing the biopsy specimen from enteringthe syringe. For example, this diameter may range from about 20 and ofthe diameter of the shank of needle 15, the needle shank commonly havingan inner diameter of about 0.05 inch.

With continued attention being directed to FIGS. 1, 2 and 6, it will beobserved that plunger 12 is secured to gripping shaft 30, with grippingshaft 30 extending outwardly from the barrel and terminating in disk 31.FIG. 2 illustrates the gripping shaft 30 having an irregular externalperiphery or configuration, with the crosssection including a centralshaft portion 33 along with a pair of radially extending ears 3434 anddetents (see FIG. 4). The shaft portion 33 along with the ears 3434 arearranged to be received within the confines of bore 35 formed in plate36, with the bore 35 including a central open portion along withradially inwardly extending members 37-37. The purpose for utilizing orproviding the radially extending members 3737 will be made manifesthereinafter. With continued attention being directed to FIGS. 2 and 4,it will be seen that the radially extending ears 34-34 are provided forthe purpose of engaging members 3737 and holding or otherwise retainingthe gripping shaft 30 in partially or fully retracted position. Thisretracted disposition enables the user to reduce the pressure within thebarrel 11, and thus establish a partial vacuum in the chambercommunicating with needle 15. This partial vacuum assists in retractingthe biopsy sample from the organ being examined, such as a sample 38,into the confines of needle 15.

As has been indicated, the technique normally employed in connectionwith the devices shown in FIGS. 16 is to initially advance the needle 15into the body of the patient from which the biopsy sample is to beobtained, with the advancement of the needle continuing until a point isreached immediately adjacent or short of the pertinent organ. Thegripping shaft is then retracted to a point at which the lugs will lockonto the surface of member 36 at 37-37, and the shaft is then rotatedarcuately so as to engage the members 3737 with the individual ears3434. The chamber 13 disposed within the barrel 11 is thereby evacuatedand a partial vacuum is formed. The needle is then advanced further witha stabbing motion so as to contact or penetrate the pertinent organ,whereupon, when needle advancement ceases, the sample is extracted fromthe organ and drawn into the confines of the needle 15. Such a sample isshown at 38 as indicated in FIG. 6.

For achieving the results with the structure of the present invention,and with particular attention being directed to FIG. 6, the tip end ofthe needle shank 16 is tapered inwardly, as illustrated at 40 in FIG. 6,this inward tapering being accomplished in order to provide a widerreceptacle area in the bore for the sample than is available at the tipor cutting edge. In this connection, an outwardly tapering angle ofbetween about 5 and 15 is considered optimum. With this construction,therefore, the sample is free to move inwardly of the core of the needleshank, and the mounting shaft blocks inward movement of the samplewithout damaging the sample. In this connection, therefore, the outerdiameter of the sample is preferably about the same diameter as thediameter of needle mounting shaft 22.

Therefore, abutment surface 24 provides an angularly disposed blockingmeans to effectively prevent continued inner movement of tissue sample38 without blocking the air flow channel and with a small or minimalarea of contact. This abutment surface further is useful in preventingthe transfer of any portion of the tissue sample 38 to the interior ofchamber 13 under the influence of vacuum.

In certain applications of the soft tissue biopsy device of the presentinvention, a liver biopsy may be taken in the transcostal approach. Inthis approach, contact with the rib surface may cause sufficientdeflection of the needle to cause fracture. The needle mounting shaft 22provides a support for the needle shaft per se, and this support reducesthe tendency toward breakage. Preferably, needle mouonting shaft 22 isprepared from stainless steel and thus is rigid and durable.Furthermore, this structure is securely held in place in the device bybeing retained directly within the inner core of boss 20.

Also, as has been indicated, the abutment surface 24 is angularlydisposed, and the communicating bore between chamber 13 and the core ofneedle 15 includes the segments 23A and 238, with segment 23B beingoff-set sufficiently from the tip end of needle mounting shaft 22 so asto prevent direct contact between the sample 38 and the bore segment23B. Such contact tends to apply concentrated forces against localizedareas of sample 38, and may cause damage or distortion of the sample,either from the surface or in the bulk.

Conventional materials of construction may be employed in these devices,with conventional plastic molded barrels and gripping shafts beingdesirable. Rubber plugs may be employed for the plunger means, andnormal needle materials may be employed for the sample-receiving needlestructures. For a general structure having substantial versatility andutility, tubing having an outer diameter of 1.4 mm, with a wallthickness of0.004 inch has been found to be desirable, along with amounting shaft having an outer diameter of about 0.04 inch and wallthickness of 0.01 inch.

I claim:

1. Biopsy aspirating means for gathering soft tissue samples comprising:

a. syringe means having a barrel, a reciprocable plunger sealinglyreceived within such barrel and forming a controllably variable volumechamber with the interior of said barrel, a sample-receiving hollowneedle having a sharpened tip, and needle mounting boss means at thebase of said barrel and extending from said barrel and having a meansreceiving the hub of said sample-receiving needle thereon;

b. a gripping shaft coupled to said plunger and extending outwardly fromsaid barrel, guide plate means disposed at the proximate end of saidbarrel and having an opening formed therein to receive said grippingshaft, said gripping shaft having locking lug means formed thereon andarranged to releasably engage the outer surface of said guide platemeans for retaining said plunger in a position removed from said barreltip means;

c. said needle mounting boss means having a central bore formed therein,a rigid needle mounting shaft disposed within said bore, said needlemounting shaft having an angularly disposed biopsy sample abutmentsurface at the forward end thereof, a bore formed within said needlemounting shaft and providing communication between said barrel and saidhollow needle shaft at an orifice at the end of said needle mountingshaft bore, said orifice being disposed at a point spaced a finitedistance from said angularly disposed sample abutment surface, saidangularly disposed abutment surface being received within the bore ofsaid hollow needle and being disposed along said needle shaft at a pointremoved from the tip end of said needle.

2. The means for gathering soft tissue biopsy samples as defined inclaim 1 and being particularly characterized in that said needlemounting boss means is compressible for grippingly engaging the innerdiameter of said needle hub.

3. The means for gathering soft tissue biopsy samples as defined inclaim 1 being particularly characterized in that said boss and angularlydisposed abutment surface are formed integrally with said barrel, andform a continuation thereof.

4. The means for gathering soft tissue biopsy samples as defined inclaim 1 being particularly characterized in that said locking lug meanson said gripping shaft are radially spaced, and radially spaced lockinglug means are formed on the outer surface of said guide plate forlockingly engaging the radially spaced locking lugs formed on saidgripping shaft and wherein the radial spacing of each of said lockinglug means facilitates free axial motion in one relative radialdisposition, with locking being established between said gripping shaftand said guide plate in a second relative radial disposition.

5. The means for gathering soft tissue biopsy samples as defined inclaim 1 being particularly characterized in that said sample abutmentsurface is formed along the forward wall of said rigid needle mountingshaft, and wherein said mounting shaft has a bore formed therein with agenerally radially extending segment and providing communication betweensaid barrel chamber and said hollow needle shaft, said radiallyextending segment being spaced inwardly of said abutment surface.

6. The means for gathering soft tissue biopsy samples as defined inclaim 1 wherein said rigid needle mounting shaft is fabricated fromstainless steel.

7. The means for gathering soft tissue biopsy samples as defined inclaim 1 being particularly characterized in that the bore formed in saidneedle mounting shaft has a diameter approximately 20 to 30% of theinner diameter of the shank portion of said sample-receiving hollowneedle.

8. The means for gathering soft tissue biopsy samples as defined inclaim 1 being particularly characterized in that the inner diameter ofsaid hollow core needle tapers inwardly at the outer tip end thereof soas to define a needle core opening having a diameter significantly lessthan the inner diameter of the shank portion thereof.

9. The means for gathering soft tissue biopsy samples as defined inclaim 8 being particularly characterized in that said inner diameter ofsaid hollow core needle tapers inwardly at an angle of between about 5and 15.

1. Biopsy aspirating means for gathering soft tissue samples comprising:a. syringe means having a barrel, a reciprocable plunger sealinglyreceived within such barrel and forming a controllably variable volumechamber with the interior of said barrel, a sample-receiving hollowneedle having a sharpened tip, and needle mounting boss means at thebase of said barrel and extending from said barrel and having a meansreceiving the hub of said sample-receiving needle thereon; b. a grippingshaft coupled to said plunger and extending outwardly from said barrel,guide plate means disposed at the proximate end of said barrel andhaving an opening formed therein to receive said gripping shaft, saidgripping shaft having locking lug means formed thereon and arranged toreleasably engage the outer surface of said guide plate means forretaining said plunger in a position removed from said barrel tip means;c. said needle mounting boss means having a central bore formed therein,a rigid needle mounting shaft disposed within said bore, said needlemounting shaft having an angularly disposed biopsy sample abutmentsurface at the forward end thereof, a bore formed within said needlemounting shaft and providing communication between said barrel and saidhollow needle shaft at an orifice at the end of said needle mountingshaft bore, said orifice being disposed at a point spaced a finitedistance from said angularly disposed sample abutment surface, saidangularly disposed abutment surface being received within the bore ofsaid hollow needle and being disposed along said needle shaft at a pointremoved from the tip end of said needle.
 2. The means for gathering softtissue biopsy samples as defined in claim 1 and being particularlycharacterized in that said needle mounting boss means is compressiblefor grippingly engaging the inner diameter of said needle hub.
 3. Themeans for gathering soft tissue biopsy samples as defined in claim 1being particularly characterized in that said boss and angularlydisposed abutment surface are formed integrally with said barrel, andform a continuation thereof.
 4. The means for gathering soft tissuebiopsy samples as defined in claim 1 being particularly characterized inthat said locking lug means on said gripping shaft are radially spaced,and radially spaced locking lug means are formed on the outer surface ofsaid guide plate for lockingly engaging the radially spaced locking lugsformed on said gripping shaft and wherein the radial spacing of each ofsaid locking lug means facilitates free axial motioN in one relativeradial disposition, with locking being established between said grippingshaft and said guide plate in a second relative radial disposition. 5.The means for gathering soft tissue biopsy samples as defined in claim 1being particularly characterized in that said sample abutment surface isformed along the forward wall of said rigid needle mounting shaft, andwherein said mounting shaft has a bore formed therein with a generallyradially extending segment and providing communication between saidbarrel chamber and said hollow needle shaft, said radially extendingsegment being spaced inwardly of said abutment surface.
 6. The means forgathering soft tissue biopsy samples as defined in claim 1 wherein saidrigid needle mounting shaft is fabricated from stainless steel.
 7. Themeans for gathering soft tissue biopsy samples as defined in claim 1being particularly characterized in that the bore formed in said needlemounting shaft has a diameter approximately 20 to 30% of the innerdiameter of the shank portion of said sample-receiving hollow needle. 8.The means for gathering soft tissue biopsy samples as defined in claim 1being particularly characterized in that the inner diameter of saidhollow core needle tapers inwardly at the outer tip end thereof so as todefine a needle core opening having a diameter significantly less thanthe inner diameter of the shank portion thereof.
 9. The means forgathering soft tissue biopsy samples as defined in claim 8 beingparticularly characterized in that said inner diameter of said hollowcore needle tapers inwardly at an angle of between about 5* and 15*.